Continuous analyte monitoring system

ABSTRACT

An improved analyte monitoring system having a sensor and a transceiver with improved communication and/or user interface capabilities. The transceiver may communicate with and power the sensor. The transceiver may receive one or more analyte measurements from the sensor and may calculate one or more analyte concentrations based on the received analyte measurements. The transceiver may generate analyte concentration trends, alerts, and/or alarms based on the calculated analyte concentrations. The system may also include a display device, which may be, for example, a smartphone and may be used to display analyte measurements received from the transceiver. The display device may execute a mobile medical application. The system may include a data management system, which may be web-based.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 15/810,822, filed on Nov. 13, 2017, which is a divisional ofU.S. patent application Ser. No. 14/580,289, filed on Dec. 23, 2014, nowU.S. Pat. No. 9,814,389, which claims the benefit of priority to U.S.Provisional Application Ser. No. 61/922,387, filed on Dec. 31, 2013,each of which is incorporated herein by reference in its entirety.

BACKGROUND Field of Invention

The present invention relates generally to measurement of an analyte ina medium of a living animal using a system including a sensor and atransceiver. Specifically, the present invention may relate to acontinuous analyte monitoring system having communication and/or userinterface capabilities.

Discussion of the Background

The prevalence of diabetes mellitus continues to increase inindustrialized countries, and projections suggest that this figure willrise to 4.4% of the global population (366 million individuals) by theyear 2030. Glycemic control is a key determinant of long-term outcomesin patients with diabetes, and poor glycemic control is associated withretinopathy, nephropathy and an increased risk of myocardial infarction,cerebrovascular accident, and peripheral vascular disease requiring limbamputation. Despite the development of new insulins and other classes ofantidiabetic therapy, roughly half of all patients with diabetes do notachieve recommended target hemoglobin A1c (HbA1c) levels <7.0%.

Frequent self-monitoring of blood glucose (SMBG) is necessary to achievetight glycemic control in patients with diabetes mellitus, particularlyfor those requiring insulin therapy. However, current blood(finger-stick) glucose tests are burdensome, and, even in structuredclinical studies, patient adherence to the recommended frequency of SMBGdecreases substantially over time. Moreover, finger-stick measurementsonly provide information about a single point in time and do not yieldinformation regarding intraday fluctuations in blood glucose levels thatmay more closely correlate with some clinical outcomes.

Continuous glucose monitors (CGMs) have been developed in an effort toovercome the limitations of finger-stick SMBG and thereby help improvepatient outcomes. These systems enable increased frequency of glucosemeasurements and a better characterization of dynamic glucosefluctuations, including episodes of unrealized hypoglycemia.Furthermore, integration of CGMs with automated insulin pumps allows forestablishment of a closed-loop “artificial pancreas” system to moreclosely approximate physiologic insulin delivery and to improveadherence. There is presently a need in the art for an improved analytemonitoring systems.

SUMMARY

The present invention overcomes the disadvantages of prior systems byproviding, among other advantages, an improved analyte monitoring systemhaving improved communication and/or user interface capabilities.

One aspect of the invention may provide a system for detecting an amountor concentration of an analyte in vivo within a living organism. Thesystem may include an analyte sensor, a transceiver configured toreceive data signals from the analyte sensor and convey analyteinformation, and a display device configured to receive analyteinformation and execute a mobile medical application that displaysanalyte concentrations.

Another aspect of the invention may provide a system for detecting anamount or concentration of an analyte in vivo within a living organism.The system may include an analyte sensor and an transceiver. In someembodiments, the transceiver can be external. In some embodiments, thereceiver can be internal. The analyte sensor may include an analyteindicator, sensor elements, and a transceiver interface device. Theanalyte indicator may be configured to exhibit a detectable propertybased on the amount or concentration of the analyte in proximity to theanalyte indicator. The sensor elements may be configured to generate adata signal based on the detectable property exhibited by the analyteindicator. The transceiver interface device may be configured to receivea power signal and generate power for powering the sensor elements andto convey data signals generated by the sensor elements. The transceivermay include a sensor interface device configured to convey the powersignal to the transceiver interface device of the analyte sensor and toreceive data signals conveyed by the transceiver interface device of theanalyte sensor.

In some embodiments, the system may include a display device and/or adata management system. The external transceiver may comprise aprocessor configured to calculate analyte concentrations based on thereceived data signals. The transceiver may include a display interfacedevice configured to convey the calculated analyte concentrations to thedisplay device. The display device may be configured to receive theanalyte concentrations conveyed by the display interface device of thetransceiver and to display the received analyte concentrations. Thedisplay device may be configured to upload the received analyteconcentrations to a web-based data management system. The display devicemay be a smartphone.

In some embodiments, the transceiver may comprise a display interfacedevice configured to convey the received data signals to a displaydevice. The system may include a display device configured to receivethe data signals conveyed by the display interface device of thetransceiver, to calculate analyte concentrations based on the receiveddata signals, and to display the calculated analyte concentrations. Thedisplay device may be configured to calculate analyte concentrationtrends based on the calculated analyte concentrations and to generatealerts or alarms based on the calculated analyte concentrations.

In some embodiments, the analyte sensor may be a fully implantablesensor. The transceiver interface device of the analyte sensor may be anantenna configured to wirelessly receive the power signal from theexternal transceiver and to wirelessly convey the data signals generatedby the sensor elements, and the sensor interface device of thetransceiver may be an antenna configured to wirelessly convey the powersignal to the antenna of the analyte sensor and to receive the datasignals from the antenna of the analyte sensor. In other embodiments,the sensor interface device of the transceiver and the transceiverinterface device of the analyte sensor may be a wire connected through atransdermal needle tip.

Another aspect of the invention may provide a transceiver including asensor interface device and a display interface device. The sensorinterface device may be configured to convey a power signal to ananalyte sensor and to receive data signals conveyed by the analytesensor. The display interface device may be configured to convey analyteinformation to a display device.

Further variations encompassed within the systems and methods aredescribed in the detailed description of the invention below.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and form partof the specification, illustrate various, non-limiting embodiments ofthe present invention. In the drawings, like reference numbers indicateidentical or functionally similar elements.

FIGS. 1A-1C are schematic views illustrating a sensor system embodyingaspects of the present invention.

FIG. 2 is cross-sectional, perspective view of a transceiver embodyingaspects of the invention.

FIG. 3 is an exploded, perspective view of a transceiver embodyingaspects of the invention.

FIG. 4 is a schematic view illustrating a transceiver embodying aspectsof the present invention.

FIG. 5 illustrates a transceiver in wireless communication with asmartphone in accordance with an embodiment of the present invention.

FIGS. 6 and 7 illustrate modes of operation for a transceiver embodyingaspects of the present invention.

FIG. 8 illustrates a mobile medical application display on a smartphoneembodying aspects of the present invention.

FIG. 9 illustrates an analyte details report generated by a datamanagement system of an analyte monitoring system embodying aspects ofthe present invention.

FIG. 10 illustrates an analyte line report generated by a datamanagement system of an analyte monitoring system embodying aspects ofthe present invention.

FIG. 11 illustrates a modal day report generated by a data managementsystem of an analyte monitoring system embodying aspects of the presentinvention.

FIG. 12 illustrates a modal summary report generated by a datamanagement system of an analyte monitoring system embodying aspects ofthe present invention.

FIG. 13 illustrates a statistics report generated by a data managementsystem of an analyte monitoring system embodying aspects of the presentinvention.

FIG. 14 illustrates a transceiver log report generated by a datamanagement system of an analyte monitoring system embodying aspects ofthe present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIGS. 1A-1C are schematic views of an analyte monitoring systemembodying aspects of the present invention. As illustrated in FIGS.1A-1C, the system may include an analyte sensor 100 and an externaltransceiver 101. In some non-limiting embodiments, the sensor 100 may bea fully implantable continuous analyte (e.g., glucose, oxygen, cardiacmarkers, low-density lipoprotein (LDL), high-density lipoprotein (HDL),or triglycerides) monitoring sensor. The sensor 100 may be implanted ina living animal (e.g., a living human). The sensor 100 may be implanted,for example, in a living animal's arm, wrist, leg, abdomen, peritoneum,intravenously, or other region of the living animal suitable for sensorimplantation. For example, in one non-limiting embodiment, the sensor100 may be implanted beneath the skin (i.e., in the subcutaneous orperitoneal tissues). In some embodiments, the sensor 100 may beimplanted subcutaneously (e.g., in a location of the body that isappropriate for subcutaneous measurement of insterstitial fluidglucose), and no portion of the sensor 100 protrudes from the skin. Insome embodiments, the sensor 100 may be an optical sensor (e.g., afluorometer). In some embodiments, the sensor 100 may be a chemical orbiochemical sensor. In some non-limiting embodiments, the sensor 100 maybe capable of being continuously implanted for at least 90 days orlonger and may replaced thereafter.

The transceiver 101 may be an electronic device that communicates withthe sensor 100 to power the sensor 100 and/or receive measurementinformation (e.g., photodetector and/or temperature sensor readings)from the sensor 100. The measurement information may include one or morereadings from one or more photodetectors of the sensor and/or one ormore readings from one or more temperature sensors of the sensors. Insome embodiments, the transceiver 101 may calculate analyteconcentrations from the measurement information received from the sensor100. However, it is not required that the transceiver 101 perform theanalyte concentration calculations itself, and, in some alternativeembodiments, the transceiver 101 may instead convey/relay themeasurement information received from the sensor 100 to another device(e.g., display device 105) for calculation of analyte concentrations(e.g., by a mobile medical application executing on the display device105).

In some embodiments, as illustrated in FIGS. 1A and 1B, the system mayinclude a display device 105. In some embodiments, the display device105 may be a portable and/or handheld device. As illustrated in FIGS. 1Aand 1B, in some embodiments, the display device 105 may be a smartphone.However, this is not required, and, in alternative embodiments, thedisplay device 105 may be a personal data assistant (“PDA”), a laptopcomputer, or a dedicated analyte monitoring display device. The displaydevice 105 may have a mobile medical application installed thereon. Insome embodiments, as illustrated in FIG. 1B, the system may include apersonal computer (PC) 109. The transceiver 101 may communicate with thedisplay device 105 and/or PC 109 through a wired or wireless connection.Moreover, in some embodiments, as illustrated in FIG. 1B, the displaydevice 105 and/or PC 109 may communicate with a data management system(DMS) 111. In some embodiments, the DMS 111 may be a web-based DMS(e.g., hosted on a remote server). In some embodiments, the displaydevice 105 may communicate with cloud storage.

In some embodiments, the analyte monitoring system may provide real-timereadings, graphs, trends, and/or analyte alarms directly to a user(e.g., via a user interface of the transceiver 101 and/or display device105). The system may be capable of being used in a home setting, and, inembodiments where the analyte is glucose, the system may aid people withdiabetes mellitus in predicting and detecting episodes of hypoglycemiaand hyperglycemia. The system may additionally or alternatively becapable of being used in clinical settings to aid health careprofessionals in evaluating analyte control. In some embodiments, thesystem may includes multiple sensors 100 (e.g., for redundancy).

In some embodiments (e.g., embodiments in which the sensor 100 is afully implantable sensor), the transceiver 101 may implement a passivetelemetry for communicating with the implantable sensor 100 via aninductive magnetic link for both power and data transfer. The sensor 100may include an inductive element 114, which may be, for example, aferrite based micro-antenna. In some embodiments, the inductive element114 may be connected to analyte detection circuitry. For example, insome embodiments, where the sensor 100 is an optical sensor, theinductive element 114 may be connected to micro-fluorimeter circuitry(e.g., an application specification integrated circuit (ASIC)) and arelated optical detection system of the sensor 100. In some embodiments,the sensor 100 may not include a battery, and, as a result, the sensor100 may rely on the transceiver 101 to provide necessary power and adata link to convey analyte-related data back to transceiver 101.

In one non-limiting embodiment, the analyte monitoring system maycontinually record interstitial fluid glucose levels in people withdiabetes mellitus for the purpose of improving diabetes management. Thetransceiver 101 may be wearable and may communicate with the sensor 100,which may be a passive, fully implantable sensor having a small size,such as, for example, the approximate size of a grain of rice. For asensor 100 that is a fully implantable sensor having no battery powersource, the transceiver 101 may provide energy to run the sensor 100 viaa magnetic field. In some embodiments, the magnetic transceiver-sensorlink can be considered as “weakly coupled transformer” type. Themagnetic transceiver-sensor link may provide energy and a link for datatransfer using amplitude modulation (AM). Although in some embodiments,data transfer is carried out using AM, in alternative embodiments, othertypes of modulation may be used. The magnetic transceiver-sensor linkmay have a low efficiency of power transfer and, therefore, may requirerelatively high power amplifier to energize the sensor 100 at longerdistances. In some non-limiting embodiments, the analyte monitoringsystem may use a frequency of 13.56 MHz, which can achieve highpenetration through the skin and is a medically approved frequency band,for power transfer. However, this is not required, and, in otherembodiments, different frequencies may be used for powering andcommunicating with the sensor 100.

In some non-limiting embodiments, the transceiver 101 may be a handhelddevice or an on-body/wearable device. For example, in some embodimentswhere the transceiver 101 is an on-body/wearable device, the transceiver101 may be held in place by a band (e.g., an armband or wristband)and/or adhesive (e.g., as part of a biocompatible patch), and thetransceiver 101 may convey (e.g., periodically, such as every twominutes, and/or upon user initiation) measurement commands (i.e.,requests for measurement information) to the sensor 100. In someembodiments where the transceiver 101 is a handheld device, positioning(i.e., hovering or swiping/waving/passing) the transceiver 101 withinrange over the sensor implant site (i.e., within proximity of the sensor100) may cause the transceiver 101 to automatically convey a measurementcommand to the sensor 100 and receive a reading from the sensor 100.

In some embodiments, as illustrated in FIG. 1C, the transceiver 101 mayinclude an inductive element 103, such as, for example, a coil. Thetransceiver 101 may generate an electromagnetic wave or electrodynamicfield (e.g., by using a coil) to induce a current in an inductiveelement 114 of the sensor 100, which powers the sensor 100. Thetransceiver 101 may also convey data (e.g., commands) to the sensor 100.For example, in a non-limiting embodiment, the transceiver 101 mayconvey data by modulating the electromagnetic wave used to power thesensor 100 (e.g., by modulating the current flowing through a coil 103of the transceiver 101). The modulation in the electromagnetic wavegenerated by the transceiver 101 may be detected/extracted by the sensor100. Moreover, the transceiver 101 may receive data (e.g., measurementinformation) from the sensor 100. For example, in a non-limitingembodiment, the transceiver 101 may receive data by detectingmodulations in the electromagnetic wave generated by the sensor 100,e.g., by detecting modulations in the current flowing through the coil103 of the transceiver 101.

The inductive element 103 of the transceiver 101 and the inductiveelement 114 of the sensor 100 may be in any configuration that permitsadequate field strength to be achieved when the two inductive elementsare brought within adequate physical proximity.

In some non-limiting embodiments, as illustrated in FIG. 1C, the sensor100 may be encased in a sensor housing 102 (i.e., body, shell, capsule,or encasement), which may be rigid and biocompatible. The sensor 100 mayinclude an analyte indicator element 106, such as, for example, apolymer graft coated, diffused, adhered, or embedded on or in at least aportion of the exterior surface of the sensor housing 102. The analyteindicator element 106 (e.g., polymer graft) of the sensor 100 mayinclude indicator molecules 104 (e.g., fluorescent indicator molecules)exhibiting one or more detectable properties (e.g., optical properties)based on the amount or concentration of the analyte in proximity to theanalyte indicator element. In some embodiments, the sensor 100 mayinclude a light source 108 that emits excitation light 329 over a rangeof wavelengths that interact with the indicator molecules 104. Thesensor 100 may also include one or more photodetectors 224, 226 (e.g.,photodiodes, phototransistors, photoresistors, or other photosensitiveelements). The one or more photodetectors (e.g., photodetector 224) maybe sensitive to emission light 331 (e.g., fluorescent light) emitted bythe indicator molecules 104 such that a signal generated by aphotodetector (e.g., photodetector 224) in response thereto that isindicative of the level of emission light 331 of the indicator moleculesand, thus, the amount of analyte of interest (e.g., glucose). In somenon-limiting embodiments, one or more of the photodetectors (e.g.,photodetector 226) may be sensitive to excitation light 329 that isreflected from the analyte indicator element 106 as reflection light333. In some non-limiting embodiments, one or more of the photodetectorsmay be covered by one or more filters that allow only a certain subsetof wavelengths of light to pass through (e.g., a subset of wavelengthscorresponding to emission light 331 or a subset of wavelengthscorresponding to reflection light 333) and reflect the remainingwavelengths. In some non-limiting embodiments, the sensor 100 mayinclude a temperature transducer 670. In some non-limiting embodiments,the sensor 100 may include a drug-eluting polymer matrix that dispersesone or more therapeutic agents (e.g., an anti-inflammatory drug).

In some embodiments, as illustrated in FIG. 1C, the sensor 100 mayinclude a substrate 116. In some embodiments, the substrate 116 may be acircuit board (e.g., a printed circuit board (PCB) or flexible PCB) onwhich circuit components (e.g., analog and/or digital circuitcomponents) may be mounted or otherwise attached. However, in somealternative embodiments, the substrate 116 may be a semiconductorsubstrate having circuitry fabricated therein. The circuitry may includeanalog and/or digital circuitry. Also, in some semiconductor substrateembodiments, in addition to the circuitry fabricated in thesemiconductor substrate, circuitry may be mounted or otherwise attachedto the semiconductor substrate 116. In other words, in somesemiconductor substrate embodiments, a portion or all of the circuitry,which may include discrete circuit elements, an integrated circuit(e.g., an application specific integrated circuit (ASIC)) and/or otherelectronic components (e.g., a non-volatile memory), may be fabricatedin the semiconductor substrate 116 with the remainder of the circuitryis secured to the semiconductor substrate 116, which may providecommunication paths between the various secured components.

In some embodiments, the one or more of the sensor housing 102, analyteindicator element 106, indicator molecules 104, light source 108,photodetectors 224, 226, temperature transducer 670, substrate 116, andinductive element 114 of sensor 100 may include some or all of thefeatures described in one or more of U.S. application Ser. No.13/761,839, filed on Feb. 7, 2013, U.S. application Ser. No. 13/937,871,filed on Jul. 9, 2013, and U.S. application Ser. No. 13/650,016, filedon Oct. 11, 2012, all of which are incorporated by reference in theirentireties. Similarly, the structure and/or function of the sensor 100and/or transceiver 101 may be as described in one or more of U.S.application Ser. Nos. 13/761,839, 13/937,871, and 13/650,016.

Although in some embodiments, as illustrated in FIGS. 1A-1C, the sensor100 may be an optical sensor, this is not required, and, in one or morealternative embodiments, sensor 100 may be a different type of analytesensor, such as, for example, a diffusion sensor or a pressure sensor.Also, although in some embodiments, as illustrated in FIGS. 1A-1C, theanalyte sensor 100 may be a fully implantable sensor, this is notrequired, and, in some alternative embodiments, the sensor 100 may be atranscutaneous sensor having a wired connection to the transceiver 101.For example, in some alternative embodiments, the sensor 100 may belocated in or on a transcutaneous needle (e.g., at the tip thereof). Inthese embodiments, instead of wirelessly communicating using inductiveelements 103 and 114, the sensor 100 and transceiver 101 may communicateusing one or more wires connected between the transceiver 101 and thetransceiver transcutaneous needle that includes the sensor 100. Foranother example, in some alternative embodiments, the sensor 100 may belocated in a catheter (e.g., for intravenous blood glucose monitoring)and may communicate (wirelessly or using wires) with the transceiver101.

In some embodiments, the sensor 100 may include a transceiver interfacedevice. In some embodiments where the sensor 100 includes an antenna(e.g., inductive element 114), the transceiver interface device mayinclude the antenna (e.g., inductive element 114) of sensor 100. In someof the transcutaneous embodiments where there exists a wired connectionbetween the sensor 100 and the transceiver 101, the transceiverinterface device may include the wired connection.

FIGS. 2 and 3 are cross-sectional and exploded views, respectively, of anon-limiting embodiment of the transceiver 101, which may be included inthe analyte monitoring system illustrated in FIGS. 1A-1C. As illustratedin FIG. 3, in some non-limiting embodiments, the transceiver 101 mayinclude a graphic overlay 204, front housing 206, button 208, printedcircuit board (PCB) assembly 210, battery 212, gaskets 214, antenna 103,frame 218, reflection plate 216, back housing 220, ID label 222, and/orvibration motor 928. In some non-limiting embodiments, the vibrationmotor 928 may be attached to the front housing 206 or back housing 220such that the battery 212 does not dampen the vibration of vibrationmotor 928. In a non-limiting embodiment, the transceiver electronics maybe assembled using standard surface mount device (SMD) reflow and soldertechniques. In one embodiment, the electronics and peripherals may beput into a snap together housing design in which the front housing 206and back housing 220 may be snapped together. In some embodiments, thefull assembly process may be performed at a single external electronicshouse. However, this is not required, and, in alternative embodiments,the transceiver assembly process may be performed at one or moreelectronics houses, which may be internal, external, or a combinationthereof. In some embodiments, the assembled transceiver may beprogrammed and functionally tested. In some embodiments, assembledtransceivers 101 may be packaged into their final shipping containersand be ready for sale.

In some embodiments, as illustrated in FIGS. 2 and 3, the antenna 103may be contained within the housing 206 and 220 of the transceiver 101.In some embodiments, the antenna 103 in the transceiver 101 may be smalland/or flat so that the antenna 103 fits within the housing 206 and 220of a small, lightweight transceiver 101. In some embodiments, theantenna 103 may be robust and capable of resisting various impacts. Insome embodiments, the transceiver 101 may be suitable for placement, forexample, on an abdomen area, upper-arm, wrist, or thigh of a patientbody. In some non-limiting embodiments, the transceiver 101 may besuitable for attachment to a patient body by means of a biocompatiblepatch. Although, in some embodiments, the antenna 103 may be containedwithin the housing 206 and 220 of the transceiver 101, this is notrequired, and, in some alternative embodiments, a portion or all of theantenna 103 may be located external to the transceiver housing. Forexample, in some alternative embodiments, antenna 103 may wrap around auser's wrist, arm, leg, or waist such as, for example, the antennadescribed in U.S. Pat. No. 8,073,548, which is incorporated herein byreference in its entirety.

FIG. 4 is a schematic view of an external transceiver 101 according to anon-limiting embodiment. In some embodiments, the transceiver 101 mayhave a connector 902, such as, for example, a Micro-Universal Serial Bus(USB) connector. The connector 902 may enable a wired connection to anexternal device, such as a personal computer (e.g., personal computer109) or a display device 105 (e.g., a smartphone).

The transceiver 101 may exchange data to and from the external devicethrough the connector 902 and/or may receive power through the connector902. The transceiver 101 may include a connector integrated circuit (IC)904, such as, for example, a USB-IC, which may control transmission andreceipt of data through the connector 902. The transceiver 101 may alsoinclude a charger IC 906, which may receive power via the connector 902and charge a battery 908 (e.g., lithium-polymer battery). In someembodiments, the battery 908 may be rechargeable, may have a shortrecharge duration, and/or may have a small size.

In some embodiments, the transceiver 101 may include one or moreconnectors in addition to (or as an alternative to) Micro-USB connector904. For example, in one alternative embodiment, the transceiver 101 mayinclude a spring-based connector (e.g., Pogo pin connector) in additionto (or as an alternative to) Micro-USB connector 904, and thetransceiver 101 may use a connection established via the spring-basedconnector for wired communication to a personal computer (e.g., personalcomputer 109) or a display device 105 (e.g., a smartphone) and/or toreceive power, which may be used, for example, to charge the battery908.

In some embodiments, the transceiver 101 may have a wirelesscommunication IC 910, which enables wireless communication with anexternal device, such as, for example, one or more personal computers(e.g., personal computer 109) or one or more display devices 105 (e.g.,a smartphone). In one non-limiting embodiment, the wirelesscommunication IC 910 may employ one or more wireless communicationstandards to wirelessly transmit data. The wireless communicationstandard employed may be any suitable wireless communication standard,such as an ANT standard, a Bluetooth standard, or a Bluetooth Low Energy(BLE) standard (e.g., BLE 4.0). In some non-limiting embodiments, thewireless communication IC 910 may be configured to wirelessly transmitdata at a frequency greater than 1 gigahertz (e.g., 2.4 or 5 GHz). Insome embodiments, the wireless communication IC 910 may include anantenna (e.g., a Bluetooth antenna). In some non-limiting embodiments,the antenna of the wireless communication IC 910 may be entirelycontained within the housing (e.g., housing 206 and 220) of thetransceiver 101. However, this is not required, and, in alternativeembodiments, all or a portion of the antenna of the wirelesscommunication IC 910 may be external to the transceiver housing.

In some embodiments, the transceiver 101 may include a display interfacedevice, which may enable communication by the transceiver 101 with oneor more display devices 105. In some embodiments, the display interfacedevice may include the antenna of the wireless communication IC 910and/or the connector 902. In some non-limiting embodiments, the displayinterface device may additionally include the wireless communication IC910 and/or the connector IC 904.

In some embodiments, the transceiver 101 may include voltage regulators912 and/or a voltage booster 914. The battery 908 may supply power (viavoltage booster 914) to radio-frequency identification (RFID) reader IC916, which uses the inductive element 103 to convey information (e.g.,commands) to the sensor 101 and receive information (e.g., measurementinformation) from the sensor 100. In some non-limiting embodiments, thesensor 100 and transceiver 101 may communicate using near fieldcommunication (NFC) (e.g., at a frequency of 13.56 MHz). In theillustrated embodiment, the inductive element 103 is a flat antenna. Insome non-limiting embodiments, the antenna may be flexible. However, asnoted above, the inductive element 103 of the transceiver 101 may be inany configuration that permits adequate field strength to be achievedwhen brought within adequate physical proximity to the inductive element114 of the sensor 100. In some embodiments, the transceiver 101 mayinclude a power amplifier 918 to amplify the signal to be conveyed bythe inductive element 103 to the sensor 100.

The transceiver 101 may include a peripheral interface controller (PIC)microcontroller 920 and memory 922 (e.g., Flash memory), which may benon-volatile and/or capable of being electronically erased and/orrewritten. The PIC microcontroller 920 may control the overall operationof the transceiver 101. For example, the PIC microcontroller 920 maycontrol the connector IC 904 or wireless communication IC 910 totransmit data via wired or wireless communication and/or control theRFID reader IC 916 to convey data via the inductive element 103. The PICmicrocontroller 920 may also control processing of data received via theinductive element 103, connector 902, or wireless communication IC 910.

In some embodiments, the transceiver 101 may include a sensor interfacedevice, which may enable communication by the transceiver 101 with asensor 100. In some embodiments, the sensor interface device may includethe inductive element 103. In some non-limiting embodiments, the sensorinterface device may additionally include the RFID reader IC 916 and/orthe power amplifier 918. However, in some alternative embodiments wherethere exists a wired connection between the sensor 100 and thetransceiver 101 (e.g., transcutaneous embodiments), the sensor interfacedevice may include the wired connection.

In some embodiments, the transceiver 101 may include a display 924(e.g., liquid crystal display and/or one or more light emitting diodes),which PIC microcontroller 920 may control to display data (e.g., glucoseconcentration values). In some embodiments, the transceiver 101 mayinclude a speaker 926 (e.g., a beeper) and/or vibration motor 928, whichmay be activated, for example, in the event that an alarm condition(e.g., detection of a hypoglycemic or hyperglycemic condition) is met.The transceiver 101 may also include one or more additional sensors 930,which may include an accelerometer and/or temperature sensor, that maybe used in the processing performed by the PIC microcontroller 920.

In some embodiments, the transceiver 101 may be a body-worn transceiverthat is a rechargeable, external device worn over the sensorimplantation or insertion site. The transceiver 101 may supply power tothe proximate sensor 100, calculate analyte concentrations from datareceived from the sensor 100, and/or transmit the calculated analyteconcentrations to a display device 105 (see FIGS. 1A, 1B, and 5). Powermay be supplied to the sensor 100 through an inductive link (e.g., aninductive link of 13.56 MHz). In some embodiments, the transceiver 101may be placed using an adhesive patch or a specially designed strap orbelt. The external transceiver 101 may read measured analyte data from asubcutaneous sensor 100 (e.g., up to a depth of 2 cm or more). Thetransceiver 101 may periodically (e.g., every 2 minutes) read sensordata and calculate an analyte concentration and an analyte concentrationtrend. From this information, the transceiver 101 may also determine ifan alert and/or alarm condition exists, which may be signaled to theuser (e.g., through vibration by vibration motor 928 and/or an LED ofthe transceiver's display 924 and/or a display of a display device 105).The information from the transceiver 101 (e.g., calculated analyteconcentrations, calculated analyte concentration trends, alerts, alarms,and/or notifications) may be transmitted to a display device 105 (e.g.,via Bluetooth Low Energy with Advanced Encryption Standard (AES)-CounterCBC-MAC (CCM) encryption) for display by a mobile medical application onthe display device 105. In some non-limiting embodiments, the mobilemedical application may provide alarms, alerts, and/or notifications inaddition to any alerts, alarms, and/or notifications received from thetransceiver 101. In one embodiment, the mobile medical application maybe configured to provide push notifications. In some embodiments, thetransceiver 101 may have a power button (e.g., button 208) to allow theuser to turn the device on or off, reset the device, or check theremaining battery life. In some embodiments, the transceiver 101 mayhave a button, which may be the same button as a power button or anadditional button, to suppress one or more user notification signals(e.g., vibration, visual, and/or audible) of the transceiver 101generated by the transceiver 101 in response to detection of an alert oralarm condition.

In some embodiments, the transceiver 101 may provide on-body alerts tothe user in a visual, audible, and/or vibratory manner, regardless ofproximity to a display device 105. In some non-limiting embodiments, asillustrated in FIG. 4, the transceiver 101 may include one or morenotification devices (e.g., display 924, beeper 926, and/or vibrationmotor 928) that generate visual, audible, and/or vibratory alerts. Insome embodiments, the transceiver 100 may be configured to vibrateand/or generate an audio or visual signal to prompt the user aboutanalyte readings outside an acceptable limit, such as hypo/hyperglycemic alerts and alarms in the case where the analyte is glucose.

In some embodiments, the vibrational, visual, and/or audible tonefeedback provided by the transceiver 101 can enable the use of differentpatterns/rhythms/melodies that have various meanings corresponding tothe status of the transceiver 101 and/or the implanted sensor 100 (e.g.,for indicating the transceiver battery power level status and/or forlocating the sensor 100 and determining the strength of connectionbetween the sensor 100 and transceiver 101), or the analyteconcentration. For example, in one non-limiting embodiment, thetransceiver 101 might be calibrated to provide a long, repeatablevibration, with or without an audible/visual alarm, when a user'sglucose concentration becomes too low or too high. In some embodiments,a vibration motor 928 of the transceiver 101 may communicate variousmessages/alerts to the user through Morse code like patterning andsequencing (e.g., long-long-short-short) and/or different vibrationspeeds and intensities. In a non-limiting embodiment, a circuit, such asupply voltage controller, may control the vibration speed andintensity. In some embodiments, different patterns of audio feedback,which may include different volumes, frequencies, time on-off (dutycycle), melodies, and/or rhythms may be used to communicate variousmessages/alerts to the user.

In some non-limiting embodiments, the transceiver 101 might becalibrated to provide a visual alert (e.g., one or more light emittingdiodes (LEDs) of display 924 may turn on and off in a specific patternand/or emit light of different intensities and/or frequencies/colors)when a user's glucose concentration becomes too low or too high. Forexample, in some non-limiting embodiments, the display 924 of thetransceiver 101 may include dual LED (e.g., yellow/green) or a tri-colorLED (i.e., blue/yellow/green). A display 924 providing different colorsmay enhance communication modes by adding color as variable. Forinstance, by using more than one LED (e.g., the dual LED or thetri-color LED) the display 924 may generate a blinkingyellow-green-yellow-etc. visual signal and/or a long yellow-shortyellow-short green-short green-etc. visual signal to communicate variousmessages/alerts to the user.

In a non-limiting embodiment, the combination of visual, audible, and/orvibratory patterns may communicate different messages/alerts than if thevisual, audible, and/or visual, audible, and/or vibratory patterns werecommunicated alone. In some embodiments, the transceiver 101 may providecertain patterns of a vibratory and/or audible and/or visual alert toprompt the user when a calibration point is needed or is going to beneeded, and/or when the battery needs to be recharged. In someembodiments, the display device 105 or other device communicating withthe transceiver 101 may also have visual, audible, or vibratory alarmsand notifications.

The vibrational, visual, and/or audible feedback of the transceiver 101can also alert the user regarding the status of the telemetry systemwith the sensor 100. For example, for systems in which transceiver 101delivers power to the implanted sensor 100 (e.g., by radio frequencysignals via an inductive antenna), the visual, audible, and/or vibratoryfeedback can prompt the subject regarding how well the two systems arecoupled. In other embodiments, the vibrational and/or audible feedbackof the transceiver 101 can assist the user in adjusting the relativeposition of the transceiver 101 and optimize coupling between thetransceiver 101 and the sensor 100 without having visual feedback. Thatis, the user can adjust the position of the transceiver 101 worn under apiece of clothing (e.g., shirt, etc.) without looking at the transceiver101—the buzzer/vibrator signals of the transceiver 101 would indicate tothe user if the sensor 100 is well within the range and if the readingsare correct. Accordingly, in some embodiments, the transceiver 101 maybe used to alert the user to optimal location of the transceiver 101over the implanted sensor, which allows the user to adjust thetransceiver 101.

In some embodiments, as illustrated in FIG. 6, there may be severalmodes of operation for the transceiver 101. The transceiver 101 mayinclude an active state 1801, which may be the normal state of thetransceiver 101. In some non-limiting embodiments, the transceiver 101,when in the active state 1801, may be in direct communication with thesensor 100 and periodically power the sensor 100 and receivemeasurements therefrom.

As illustrated in FIG. 6, the transceiver 101 may include a transceiverplacement state 1803. The transceiver 101 may enter the transceiverplacement state 1803 from the active state 1801 if the transceiver 101does not detect the sensor 100. When in the transceiver placement state1803, the transceiver 101 may actively search for (i.e., attempt tolocate) the sensor 100. In some non-limiting embodiments, thetransceiver 101 may attempt to locate the sensor 100 by measuring thestrength of magnetic coupling between the inductive elements 103 and 114of the transceiver 101 and sensor 100 such as, for example, in themanner described in U.S. application Ser. No. 13/650,016, filed on Oct.11, 2012, which is incorporated herein by reference in its entirety. Thetransceiver 101 may also include a battery check state 1805. Thetransceiver 101 may enter the battery check state 1805 from the activestate 1801 if a button (e.g., button 208) on the transceiver 101 ispressed, and, when in the battery check state 1805, the display 924 ofthe transceiver 101 may show the remaining battery life of thetransceiver 101.

In some embodiments, the transceiver 101 may include a sleep state 1807.In one non-limiting embodiment, the transceiver 101 may enter the sleepstate 1807 from the active state 1801 if the transceiver button (e.g.,button 208) is held for longer than a threshold period of time (e.g., 30seconds). The transceiver 101 may include a discoverable/pairing state1809. The transceiver 101 may enter the discoverable/pairing state 1809from the sleep state 1807 if the transceiver is held for longer than athreshold period of time (e.g., 10 seconds). In the discoverable/pairingstate 1809, the transceiver 101 may be paired with a display device 105(e.g., a Bluetooth enabled smartphone).

As illustrated in FIG. 7, the transceiver 101 may include a chargingstate 1909. The transceiver 101 may enter the charging state 1909 whenthe transceiver 101 is plugged into a charging system (e.g., viaconnector 902). While in the charging state 1909, the display 924 of thetransceiver 101 may indicate that the transceiver 101 is charging (e.g.,by an LED of the display 924 emitting yellow light) and/or may indicatethat charging is complete (e.g., by an LED of the display 924 emittinggreen light).

As illustrated in FIG. 7, the transceiver 101 may include a reset state1911. The transceiver 101 may enter the reset state 1911 in response toa user input (e.g., holding a transceiver button for more than apredetermined amount of time, such as, for example, 30 seconds). Whilein the reset state 1911, the transceiver 101 may return to its originalsettings.

As illustrated in FIG. 7, the transceiver 101 may include a fault state1913. The transceiver 101 may enter the fault state 1913 if thetransceiver 101 detects an internal problem. While in the fault state1913, the transceiver 101 may alert the user that the transceiver 101 isnot working properly (e.g., by an LED of display 924 emitting amber orred light).

As illustrated in FIG. 7, the transceiver 101 may include a dormantstate 1915. The transceiver 101 may enter the dormant state 1913 if thetransceiver 101 detects that the battery life of battery 908 falls belowa threshold (e.g., 5% of capacity). While in the dormant state 1915, thetransceiver 101 may alert the user that battery life is low and that thebattery should be recharged.

In some embodiments, the transceiver 101 may pass between states (e.g.,the states described above with reference to FIGS. 6 and 7) under thecontrol of the microcontroller 920. In other words, the microcontroller920 may be configured to control the transceiver 101 in the transceiverstates and to pass from one state to another.

In some embodiments, the transceiver 101 may store the measurementinformation received from the sensor 100 (e.g., in memory 922). As notedabove, the measurement information received from the sensor 100 mayinclude one or more of: (i) a signal channel measurement with lightsource 108 on, (ii) a reference or second signal channel measurementwith light source 108 on, (iii) a light source current source voltagemeasurement, (iv) field current measurement, (v) a diagnosticmeasurement, (vi) an ambient signal channel measurement with lightsource 108 off, (vii) an ambient reference or second signal channelmeasurement with light source 108 off, and (viii) a temperaturemeasurement. In some embodiments, the transceiver 101 may additionallystore (e.g., in memory 922) other data with the measurement informationreceived from the sensor 100. In some non-limiting embodiments, theother data may include one or more of: (i) an analyte concentration(e.g., in mg/dL, such as, for example, within a range of 20.0 to 400.0mg/dL) calculated by the transceiver 101 from the measurementinformation, (ii) the date and time that the analyte measurement wastaken, (iii) accelerometer values (e.g., x, y, and z) taken from anaccelerometer of the transceiver 101 (e.g., an accelerometer ofadditional sensors 930), and/or (iv) the temperature of the transceiver101 as measured by a temperature sensor of the transceiver 101 (e.g., atemperature sensor of additional sensors 930). In some embodiments, thetransceiver 101 may keep track of the date and time and, as noted above,store the date and time along with the received analyte measurementinformation and/or calculated analyte concentration. In embodimentswhere the transceiver 101 includes an accelerometer, the accelerometerwill enable tracking of activity levels of the subject that is wearingthe transceiver 101. This activity level may be included in an event logand incorporated into various algorithms (e.g., for analyteconcentration calculation, trending, and/or contributing to potentialdosing levels for the subjects). In some embodiments, the transceiver101 may store (e.g., in memory 922) any alert and/or alarm conditionsdetected based on the calculated analyte concentrations.

In some embodiments, the transceiver 100 may include a GlobalPositioning System (GPS) unit having the functionality to acquire a GPSsignal. The GPS unit may implement hardware and/or softwarefunctionality that enables monitoring of motion. In some non-limitingembodiments, the GPS unit may improve glucose monitoring by providingmotion information that can be used to help determine movement-relatedartifacts or noise that may be present within the monitoring signal. Insome embodiments, the transceiver 100 may additionally or alternativelyuse information from the GPS unit to provide feedback to the user of thesensor system in order to aid the user in, for example, moving thesensor 324 to the correct position or orientation. In some embodiments,the GPS unit may provide the transceiver 100 with the ability tocommunicate exact positions for patients that may go into hypoglycemicshock and would need emergency personal notified of their location fortreatment. For example, the location of the patient may be communicatedthrough the transceiver's wireless capabilities and/or through acellular or wifi handset.

In some embodiments, the mobile medical application executing on thedisplay device 105 may be configured to send text messages and/or emailsto other devices (e.g., at telephone numbers and/or email addresses offamily members, guardians, emergency contacts, doctors, medical staff,etc.) with information regarding analyte status (e.g., analyteconcentrations, trends, alerts, alarms, notifications).

In some embodiments, the transceiver 101, sensor 100, or mobile medicalapplication executing on a display device 105 may initiate a call (e.g.,via a display device 105 that is a smartphone) to appropriate emergencynumber in case of an emergency. In one embodiment, a wearable externaltransceiver 101 or a user interface displayed by the mobile medicalapplication executing on a display device 105 may include an emergencybutton that will initiate a call with the emergency number for the livelocation of the patient. In this embodiment, the patient may enteremergency contact information through a software program. For example,in a non-limiting embodiment, the patient's doctor will have access tothe software and input the emergency contact information during adoctor's visit, and/or the patient will have access to a web interfacewhere the patient can login and enter the emergency contact informationthemselves. The emergency contact information may be stored on anexternal device (e.g., a remote server) or as data in the externaltransceiver 101, implanted sensor 100, or display device 105. In onenon-limiting embodiment, in case of an emergency, pressing the emergencybutton on the transceiver 101 and/or analyte levels reaching dangerouslevels for an extended period of time may cause the transceiver 101 toautomatically transmit a signal to a display device 105 or other devicethat will call a programmed caregiver or hospital depending on thepatient's location.

In one non-limiting embodiment, transceiver 101 will send a signal tocall the programmed emergency contact if it senses low (or high) analyteand idle movement for an extended period of time (e.g.,latitude/longitude not changing in GPS tracker) along a roadway, river,etc. The transceiver 101 or sensor 100 may include a timerpre-programmed to a specific length of time and may generate an initial“no movement detected/low analyte” alert that will sound a cell phone(e.g., a display device 105 that is a smartphone) or other similardevice before initiating an emergency contact. The patient may be ableto silence the alert if they are not moving on purpose (e.g., sitting ina movie, concert, or long car ride), but, because the alert alsoindicates a low (or high) analyte concentration, the patient will beable to alleviate the issue and raise (or lower) their analyte levelbefore the levels drop too low (or go too high). In some embodiments,transceiver 101 may alert a cell phone (e.g., a display device 105 thatis a smartphone) or other device when an analyte concentration is low orhigh and indicate where the nearest market, clinic, and/or pharmacy isbased upon the patient's location.

In some embodiments where the transceiver 101 has a GPS unit, thetransceiver may adjust analyte concentration calculations based on thealtitude of the patient. In doing so, the analyte monitoring system mayensure that analyte readings remain accurate even with changingaltitude.

In some embodiments, the transceiver 100 may include splash-proof/waterresistant or waterproof features. This would enable the user to use thetransceiver 100 according to appropriate guidelines of those standards.For example, in embodiments where the transceiver 100 is waterproof, auser could take as shower while wearing the waterproof transceiver 100.

In some embodiments, as illustrated in FIG. 8, the display device 105may have a mobile medical application installed thereon that, whenexecuted by the display device 105, displays analyte values (e.g., “124mg/dL”), trends (e.g., upward or downward), graphs, alerts (e.g.,“glucose above target”), and/or alarms (e.g., indicating that ahyperglycemic or hypoglycemic condition has been reached). In someembodiments, the transceiver 101 may calculate the analyteconcentrations and trends and detect the alert and/or alarm conditionsand push the concentrations, trends, alerts, and/or alarms to thedisplay device 105 for display. In this way, transceiver 101 may updatedata displayed by the display device 105 (i.e., the data displayed bythe display device 105 may be synchronized with the data calculated bythe transceiver 101), and the display device 105 may mirror datacalculated by and received the transceiver 101 by displaying it to theuser. In some embodiments, the display device 105 does not perform itsown calculations, but this is not required, and, in some alternativeembodiments, the medical application executed on a display device 105may calculate analyte concentrations and/or trends and/or detect alertand/or alarm conditions based on data received from the transceiver 101.In some embodiments, the transceiver 101 may not display the calculatedconcentrations and/or trends itself. However, this is not required, and,in some alternative embodiments, the transceiver 101 and one or moredisplay devices 105 may redundantly display the calculatedconcentrations and/or trends. In one non-limiting embodiment, thetransceiver 101 (i) calculates but does not display analyteconcentrations and trends, (ii) detects alert and alarm conditions andnotifies the user of detected alert and alarm conditions (e.g., viavibration, audible, and/or visual feedback), and (iii) pushes thecalculated analyte concentrations and trends and the detected alerts andalarms to a display device 105 for display by the medical application.In some embodiments, the mobile medical application allows the user toset predetermined alarm and alert thresholds.

In some embodiments, transceiver 101 (or the display device 105 in somealternative embodiments) calculate an analyte concentration trend byestimating the slope between the analyte concentration calculated fromthe previous sensor reading and the analyte concentration calculatedfrom the current sensor reading. In some embodiments, the trend may berecalculated at every sensor reading. A user may use the trend to knowhow to respond to their analyte level more effectively in order to keepit in a healthy range. In some non-limiting embodiments where theanalyte is glucose, the glucose trend/rate between two data points maybe calculated as follows:

Rate=(G _(New) −G _(Old))/(T _(Old) −T _(New))   (1)

where: G_(New)=average of three most recent glucose measurements,G_(Old)=average of next three most recent glucose measurements,T_(New)=average time at which three most recent glucose measurementswere taken, and T_(Old)=average time at which next three most recentglucose measurement were taken. However, this is not required, and, inalternative embodiments, the transceiver 101 may calculate the trend indifferent ways.

In some embodiments where the analyte is glucose and the system includesthe display device 105, a user may have the option of using a mobilemedical application executed by the display device 105 to set target,alert, and/or alarm levels for hypoglycemia and hyperglycemia so thatthe user's glucose levels stay within the eugylcemia range, which isbetween about 75 and 165 mg/dL for a normal person. In some non-limitingembodiments, the user may set an alert level, and, when the calculatedglucose concentration reaches a level that is too low (hypoglycemia) ora level that is too high (hyperglycemia), the smartphone may warn/alertthe user (e.g., by beeping briefly, vibrating briefly, and/or displayingan alert message on a background having a first color, such as yellow).In some non-limiting embodiments, a user may set an alarm level, whichis a level at which the value of glucose is significantly too high orlow, and, when the calculated glucose concentration reaches an alarmlevel, the display device 105 may warn the user using an alarm (e.g., alonger beep, a longer vibration, and/or an alarm message on a backgroundhaving a second color, such as red) that is distinguishable from thealert indicating that the alert level has been reached.

In some embodiments, the mobile medical application executed by thedisplay device 105 may be configured to accept user-enteredphysiological events, log the events, and display the events. In somenon-limiting embodiments, the physiological events may include, forexample, insulin, meal/carb, exercise, and/or health/illness events. Insome embodiments, the mobile medical application may display the eventson a graph plotting the calculated analyte concentrations. FIG. 9includes an example of a display device 105 displaying a logged exerciseevent and a logged meal event on a graph plotting analyteconcentrations.

In some embodiments where the system includes the data management system(DMS) 111 (see FIG. 1B), the DMS 111 may be a web-based analyte DMS. Insome embodiments, data from the display device 105 and/or PC 109 may beuploaded (e.g., through a wired connection such as, for example, a USBconnection or a wireless connection such as, for example, a wirelessInternet connection) to a web server on a remote computer. In someembodiments, the DMS 111 may enable sharing of the analyte data (e.g.,allowing the user, caregiver, and/or clinician to view sensor analytedata). The user may collect analyte data at home or in a clinic/researchfacility and then upload the data to their computer web account. Usingthe web account, the DMS 111 may use the data to generate one or moredifferent reports utilizing the uploaded information. For example, insome non-limiting embodiments, the DMS 111 may use the uploaded data togenerate one or more of the following reports: (i) an analyte detailsreport, (ii) an analyte line report, (iii) a modal day report, (iv) amodal summary report, (v) a statistics report, and (vi) a transceiverlog report. Examples of the different reports that may be generated bythe DMS 111 are illustrated in FIGS. 9-14, respectively.

In some embodiments, a user may use the DMS 111 to register with the DMS111 and create a unique user ID and password. Once logged in, the usermay enter their basic user information and may upload analyte readingdata from their transceiver 101. In various embodiments, the DMS 111 maysupport specific data types such as, for example, glucose, insulin,meal/carbs, exercise, health event, alarms, and errors. In somenon-limiting embodiments, data can be automatically uploaded or enteredmanually by the user or imported from the transceiver 101 and then savedin the DMS 111 to be viewed at a later date.

In some embodiments, the each sensor 100 and/or each transceiver 101 mayinclude traceability information, such as, for example, a uniqueidentifier. In some embodiments, a transceiver 101 may receive a uniqueidentifier from a sensor 100 and decode the unique identifier. Based onthe decoded unique identifier, the transceiver 101 may identify thesensor's manufacturing information, which may be useful in purifyinganalyte measurements received from the sensor 100 and/or calculatinganalyte concentration. For example, in some non-limiting embodiments,the transceiver 101 may use manufacturing information to purify receivedanalyte measurements and/or calculate analyte concentrations in themanner described in U.S. application Ser. No. 13/937,871, filed on Jul.9, 2013, which is incorporated herein by reference in its entirety. Insome non-limiting embodiments, the transceiver 101 may be capable ofcalculating analyte concentrations in units of mg/dL and/or mmol.

In some embodiments, the sensor 100 may receive a unique identifier of atransceiver 101 and use the transceiver's unique identifier to determinewhether the transceiver 101 is a different transceiver 101 than thetransceiver 101 last used with the sensor 100 and/or whether thetransceiver 101 has not been previously used with the sensor 100. Thesensor 100 may use this information to determine whether to convey anyprevious analyte measurement information stored on the sensor 100 to thetransceiver 101 to update/fill in any gaps in the transceiver's records.Additionally or alternatively, in some embodiments, a display device 105and/or web-based DMS 111 may use a unique identifier of a transceiver101 to determine whether to convey information such as, for example,calibration information and/or user preferences to the transceiver 101.

In some embodiments, the transceiver 101 may perform a calibrationregimen. In some non-limiting embodiments, the transceiver 101 maycalibrate itself using analyte measurements received from the sensor 100and one or more analyte calibration measurements (e.g., finger-stickself-monitoring blood glucose (SMBG) measurements). In some non-limitingembodiments, the user may wait until after the sensor 100 has beenimplanted for 24 hours to calibrate the sensor 100. In some non-limitingembodiments, the user may calibrate the sensor 100 using four fingerstick measurements each separated by at least two hours. After aninitial calibration, the system may request one or more additionalfinger stick measurements to recalibrate the sensor 100. For example, inone non-limiting embodiment, after the initial calibration, the systemmay request two finger stick measurements (i.e., calibration datapoints) each day, and the finger stick measurements may be separated by10-14 hours. In some non-limiting embodiments, a user may enter analytecalibration measurements using the medical application executed by thedisplay device 105 and/or the DMS 111, and the transceiver 101 maydownload the entered analyte calibration measurements from the displaydevice 105 and/or the DMS 111.

For instance, in one particular non-limiting embodiment where theanalyte is glucose, the calibration regimen may involve three phases:(i) a warm-up phase during the first 24 hours after implantation inwhich glucose levels are not calculated, (ii) an initialization phasestarting at 24 hours after implantation and ending after acquiring fourfinger-stick SMBG calibration points separated by a minimum of 2 hours,and (iii) a daily calibration phase starting after the last calibrationof the initialization phase. In some embodiments, the user may set thedaily calibration times (e.g., 8 am and 6 pm). In some non-limitingembodiments, analyte calibration measurements may be limited tocalibration points falling within specified ranges (e.g., glucosereadings greater than 60 mg/dL and less than 300 mg/dL during rates ofglucose change less than 2.5 mg/dL/min). In some embodiments, the usermay enter the calibration points of the initialization phase and/ordaily calibration phase into the analyte monitoring system via a userinterface of the transceiver 101 or display device 105. In non-limitingembodiments where the user enters the calibration points via the userinterface of the display device 105, the display device 105 may conveythe entered calibration points to the transceiver via wired or wirelesscommunication.

In some embodiments, the analyte monitoring system may include aninsulin pump, and the transceiver 101 and/or a display device 105 mayconvey analyte concentrations and/or insulin delivery commands to aninsulin pump controller, which may adjust the insulin output of theinsulin pump as part of a closed-loop insulin delivery system (i.e.,artificial pancreas).

Embodiments of the present invention have been fully described abovewith reference to the drawing figures. Although the invention has beendescribed based upon these preferred embodiments, it would be apparentto those of skill in the art that certain modifications, variations, andalternative constructions could be made to the described embodimentswithin the spirit and scope of the invention.

For example, although embodiments have been described in which thetransceiver 101 (e.g., the microcontroller 920 of transceiver 101)calculates analyte concentrations based on the measurement information,this is not required. In some alternative embodiments, the transceiver101 may instead covey/relay the measurement information received fromthe sensor 100 to another device for calculation of analyteconcentrations without performing analyte concentration calculations. Insome non-limiting alternative embodiments, the transceiver 101 may relayanalyte measurement information received from the sensor 100 to thedisplay device 105. A mobile medication application executing on thedisplay device 105 may calculate analyte concentrations based on themeasurement information received from the transceiver 101. In somenon-limiting alternative embodiments, the display device 105 may purifyreceived analyte measurement information and/or calculate analyteconcentrations in the manner described in U.S. application Ser. No.13/937,871, filed on Jul. 9, 2013, which is incorporated herein byreference in its entirety. Also, in some non-limiting embodiments, thedisplay device 105 may calculate analyte concentration trends(regardless of whether calculation of the analyte concentrations isperformed by the transceiver 101 or the display device 105).

What is claimed is:
 1. A system for detecting an amount or concentrationof an analyte in vivo within a living organism, the system comprising:(A) an analyte sensor comprising: (A1) an analyte indicator configuredto produce a detectable property based on the amount or concentration ofthe analyte in proximity to the analyte indicator; (A2) sensor elementsconfigured to generate a data signal based on the detectable propertyproduced by the analyte indicator; and (A3) a transceiver interfacedevice configured to convey data signals generated by the sensorelements; (B) a transceiver comprising: (B1) a sensor interface deviceconfigured to receive the data signals conveyed by the transceiverinterface device of the analyte sensor; (B2) a processor configured to:calculate analyte concentrations based on the received data signals, andperform an analyte concentration calibration based on one or moreuser-entered calibration points; and (B3) a display interface deviceconfigured to wirelessly convey the calculated analyte concentrations toa display device and wirelessly receive the one or more user-enteredcalibration points from the display device; and (C) a display deviceconfigured to receive the analyte concentrations conveyed by the displayinterface device of the transceiver, to display the received analyteconcentrations, and to facilitate user entry of the calibration points.2. The system of claim 1, wherein the analyte sensor is an implantablesensor.
 3. The system of claim 1, wherein the display device is asmartphone.
 4. The system of claim 1, wherein the wireless communicationcircuit employs a wireless communication standard to wirelessly conveythe calculated analyte concentrations.
 5. The system of claim 4, whereinthe wireless communication standard is a Bluetooth standard.
 6. Thesystem of claim 1, wherein the transceiver does not display thecalculated analyte concentrations.
 7. The system of claim 1, wherein theanalyte sensor further comprises a sensor housing, and the sensorelements and transceiver interface device are contained within thesensor housing.
 8. The system of claim 1, wherein the detectableproperty is an optical property.
 9. The system of claim 1, wherein thesensor elements comprise a light source and a photodetector.
 10. Thesystem of claim 1, wherein the analyte is glucose.
 11. The system ofclaim 1, wherein the transceiver interface device of the analyte sensorcomprises an antenna configured to wirelessly convey the data signalsgenerated by the sensor elements, and the sensor interface device of thetransceiver comprises an antenna configured to wirelessly receive thedata signals from the antenna of the analyte sensor.
 12. The system ofclaim 11, wherein the antennas of the analyte sensor and the transceiverare inductive elements.
 13. The system of claim 1, wherein the sensorinterface device of the transceiver and the transceiver interface deviceof the analyte sensor are a wire connected through a transdermal needletip.
 14. A system for detecting an amount or concentration of an analytein vivo within a living organism, the system comprising: (A) an analytesensor comprising: (A1) an analyte indicator configured to produce adetectable property based on the amount or concentration of the analytein proximity to the analyte indicator; (A2) sensor elements configuredto generate a data signal based on the detectable property produced bythe analyte indicator; and (A3) a transceiver interface deviceconfigured to convey data signals generated by the sensor elements; (B)a transceiver comprising: (B1) a sensor interface device configured toreceive the data signals conveyed by the transceiver interface device ofthe analyte sensor; and (B2) a display interface device configured towirelessly convey the received data signals to a display device; and (C)a display device configured to: receive the data signals conveyed by thedisplay interface device of the transceiver, calculate analyteconcentrations based on the received data signals, display thecalculated analyte concentrations, perform an analyte concentrationcalibration based on one or more user-entered calibration points, andfacilitate user entry of the calibration points.
 15. The system of claim20, wherein the display device is a smartphone.
 16. A method fordetecting an amount or concentration of an analyte in vivo within aliving organism, the method comprising: using an analyte indicator of ananalyte sensor of a system to produce a detectable property based on theamount or concentration of the analyte in proximity to the analyteindicator; using sensor elements of the analyte sensor to generate adata signal based on the detectable property exhibited by the analyteindicator; using a transceiver interface device of the analyte sensor toconvey data signals generated by the sensor elements; using a sensorinterface device of a transceiver of the system to receive the datasignals conveyed by the transceiver interface device of the analytesensor; using a processor of the transceiver to calculate analyteconcentrations based on the received data signals; using the processerof the transceiver to perform an analyte concentration calibration basedon one or more user-entered calibration points; using a displayinterface device of the transceiver to wirelessly convey the calculatedanalyte concentrations to a display device; using the display interfacedevice to wirelessly receive the one or more user-entered calibrationpoints from the display device; using a display device of the system toreceive the analyte concentrations conveyed by the display interfacedevice of the transceiver; using the display device to display thereceived analyte concentrations; and using the display device tofacilitate user entry of the calibration points.
 17. The method of claim16, wherein using the transceiver interface device of the analyte sensorto convey the data signals generated by the sensor elements comprisesusing an antenna of the transceiver interface device to wirelesslyconvey the data signals generated by the sensor elements, and using thesensor interface device of the transceiver to receive the data signalsconveyed by the transceiver interface device of the analyte sensorcomprises using an antenna of the sensor interface device of thetransceiver to wirelessly receive the data signals from the antenna ofthe transceiver interface device of the analyte sensor.
 18. A method fordetecting an amount or concentration of an analyte in vivo within aliving organism, the method comprising: using an analyte indicator of ananalyte sensor to produce a detectable property based on the amount orconcentration of the analyte in proximity to the analyte indicator;using sensor elements of the analyte sensor to generate a data signalbased on the detectable property produced by the analyte indicator;using a transceiver interface device of the analyte sensor to conveydata signals generated by the sensor elements; using a sensor interfacedevice of a transceiver to receive the data signals conveyed by thetransceiver interface device of the analyte sensor; using a displayinterface device of the transceiver to wirelessly convey the receiveddata signals to a display device; using a display device to receive thedata signals conveyed by the display interface device of thetransceiver; using the display device to calculate analyteconcentrations based on the received data signals; using the displaydevice to display the calculated analyte concentrations; using thedisplay device to perform an analyte concentration calibration based onone or more user-entered calibration points; and using the displaydevice to facilitate user entry of the calibration points.
 19. Themethod of claim 18, wherein using the transceiver interface device ofthe analyte sensor to convey the data signals generated by the sensorelements comprises using an antenna of the transceiver interface deviceto wirelessly convey the data signals generated by the sensor elements,and using the sensor interface device of the transceiver to receive thedata signals conveyed by the transceiver interface device of the analytesensor comprises using an antenna of the sensor interface device of thetransceiver to wirelessly receive the data signals from the antenna ofthe transceiver interface device of the analyte sensor.
 20. The methodof claim 18, wherein the display device is a smartphone.